Reported Mar 4, 2020 · Terminated
Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion, Sterile Solution, 100 mL Single…
Breckenridge Pharmaceutical, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Breckenridge Pharmaceutical, Inc · 15 Massirio Dr Ste 201 · Berlin, CT · 06037-2352
Is this the product you have?
- Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion, Sterile Solution, 100 mL Single - Dose Vial per Carton, Rx Only
- Distributed byBreckenridge Pharmaceutical, Inc., Boca Raton, FL 33487
- Manufactured byPharmaceutics International, Inc., Hunt Valley, MD 21031, NDC 51991-064-98
- Lot codes and dates
Lot # 5553.044E5553.044FExp. 04/30/2021
- Amount recalled
- 900 Vials
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Breckenridge Pharmaceutical, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.